Cleared Traditional

SPACELABS PATHFINDER SL HOLTER ANALYZER (K110001) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110001 · Spacelabs Healthcare, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
162d
Days
Class 2
Risk

K110001 is an FDA 510(k) clearance for the SPACELABS PATHFINDER SL HOLTER ANALYZER. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Spacelabs Healthcare, Ltd. (Nederland, US). The FDA issued a Cleared decision on June 14, 2011 after a review of 162 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Spacelabs Healthcare, Ltd. devices

Submission Details

510(k) Number K110001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2011
Decision Date June 14, 2011
Days to Decision 162 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 125d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 184
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K110001.
iLab Polaris Multi-Modality Guidance System
K151613 · Boston Scientific Corporation · Oct 2015
V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
K141185 · Boston Scientific Corp · Jun 2014
MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
K111200 · Ge Healthcare · Oct 2011
MARS HOLTER ANALYSIS WORKSTATION
K093141 · Ge Medical Systems Information Technologies · Dec 2009
MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
K083639 · Ge Medical Systems Information Technologies · Feb 2009
MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM
K072502 · Ge Medical Systems Information Technologies · Nov 2007